The Manufacturing Quality Associate performs a wide variety of Quality Assurance activities to ensure compliance with related regulatory requirements. Writes, revises, and processes cGMP documents such as: Standard Operating Procedures (SOPs), Forms, and Batch Records. May conduct investigations related to manufactured products. Understand the cGMPs and processes such as Quality Systems (e.g., Deviations, Corrective and Preventive Action reports, Change Controls, and Out of Specifications). Ensure cGMP and regulatory compliance as defined in government regulations such as 21 CFR Parts 11, 210, 211, and 600, as well as compliance with corporate policies and procedures. Perform review of the IgG Manufacturing documents, including but not limited to on the floor batch record reviews and forms to ensure compliance with SOPs and regulatory requirements. Write Deviations as found during reviews of IgG Manufacturing documents.The Manufacturing Quality Associate writes Good Documentation Practices forms as found during reviews of IgG Manufacturing documents and write and investigate CAPA’s as needed. Work with IgG Manufacturing floor personnel to resolve documentation issues. Write and revise MFG SOPs including developing new procedures when necessary. Trends GMP and GDP issues and develops training, corrective actions and metrics. Review SOPs and documents in revision for accuracy and completeness. Assist in failure investigations including support in the identification of root causes and corrective actions. Assist with new employee and on-going cGMP and quality related training as required. Coordinate and perform any additional activities or projects assigned by IgG Management.
A Bachelor’s Degree preferred but can be offset by experience. Three to five years’ experience in pharmaceutical or biotechnology industry or other related industry. Previous knowledge of scientific, medical and regulatory terms. Ability to use personal computer and software including word processing, spreadsheet and database. Demonstrated organizational skills with close attention to detail and accuracy. Good verbal communication skills to effectively train employees. Demonstrated good problem solving skills with minimal supervision. Mathematical skills including the use of calculations involving fractions, decimals and percentages.